BEUDAMED
    228 results · 20ms · Sources: EU EUDAMED, US FDA

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    BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

    FDA Enforcement
    Class II ·Terminated·O-Two Medical Technologies, Inc.·August 29, 2018

    Zimmer CAS

    Manufacturer
    🇨🇦 Canada·1 Importer

    ZIMMER CAS

    FDA registration
    ZIMMER CAS·24 products·🇨🇦 Canada

    Coroneo Inc.

    Manufacturer
    🇨🇦 Canada·49 Basic UDI-DIs·49 Devices·2 Importers·GMED SAS and GMED SAS

    MY01 Inc.

    Manufacturer
    🇨🇦 Canada·2 Basic UDI-DIs·4 Devices·1 Importer·GMED SAS

    Meditech International Inc

    Manufacturer
    🇨🇦 Canada·18 Basic UDI-DIs·18 Devices·1 Importer·GMED SAS

    bioLytical Laboratories Inc.

    Manufacturer
    🇨🇦 Canada·38 Basic UDI-DIs·38 Devices·Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, and Presafe Denmark A/S

    VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

    Device
    EU MDR · Eu Md Class 1 ·14190777 Canada Inc·On the market·3 countries

    PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.

    FDA Enforcement
    Class II ·Terminated·Zimmer CAS·December 10, 2014

    Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;

    FDA Enforcement
    Class II ·Terminated·Zimmer CAS·June 10, 2015

    Extra Aortic

    Device
    EU MDD · Eu Md Class 3 ·Coroneo Inc.·On the market·13 countries

    Extra Aortic

    Device
    EU MDD · Eu Md Class 3 ·Coroneo Inc.·On the market·13 countries

    Extra Aortic

    Device
    EU MDD · Eu Md Class 3 ·Coroneo Inc.·On the market·13 countries

    Extra Aortic

    Device
    EU MDD · Eu Md Class 3 ·Coroneo Inc.·On the market·13 countries

    Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument

    FDA Enforcement
    Class III ·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017

    SmartTools Knee System Orthopedic Stereotaxic Instrument

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·April 26, 2017

    Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 3, 2017

    Navitrack System - OS Knee Universal, Stereotaxic instrument

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017

    Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·June 14, 2017